BEUDAMED
    15 results · 19ms · Sources: EU EUDAMED, US FDA

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    SONTEK INFUSION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RAMSOFT PACS, MODEL 3.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    BREATHE NIOV VENTILATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FLOEY CATHETER W TEMP

    FDA Adverse Event
    Injury ·DEGANIA SILICONE LTD·Product code DRF·October 17, 2017

    FOLEY CATHETER W TEMP

    FDA Adverse Event
    Malfunction ·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017

    FOLEY CATHETER W TEMP

    FDA Adverse Event
    Malfunction ·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017

    TORQUE WRENCH

    FDA Adverse Event
    Malfunction ·DEPUY SPINE INC·Product code HXC·April 2, 2021

    FOLEY CATHETER W TEMP

    FDA Adverse Event
    Malfunction ·DEGANIA SILICONE LTD.·Product code KOD·July 7, 2017

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·November 14, 2012

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code LWP·June 10, 2015

    MAXCEM ELITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·September 10, 2010

    FOLEY CATHETER W TEMP

    FDA Adverse Event
    Malfunction ·MMJ SA DE CV (USD)·Product code DRF·November 9, 2018

    TORQUE WRENCH

    FDA Adverse Event
    Malfunction ·DEPUY SPINE INC·Product code HXC·September 9, 2024

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017